[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424108":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":19,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":19,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Baptist Health South Florida","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Radiotherapy","Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy",[12],"Radiation: Spine stereotactic body radiotherapy",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"RADIATION","Spine stereotactic body radiotherapy","Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.\n\nCohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Rupesh Kotecha, MD","Miami Cancer Institute (MCI) at Baptist Health, Inc.","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","786-596-2000","RupeshK@baptisthealth.net",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Antoinette Pimentel","17865962000","antoinette.pimentel@baptisthealth.net",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Miami Cancer Institute at Baptist Health, Inc","RECRUITING","Miami","Florida","33176","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-80.19366,25.77427,{"lat":47,"lon":46},[50,51],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100424108","dose-escalated-spine-sbrt-for-localized-metastasis-to-the-spinal-column-100424108",false,"NCT04802603","Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column","Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column","DESSRT","Inclusion Criteria:\n\n* Zubrod Performance Status 0-2\n* Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)\n* Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion\n* Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis\n* For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months\n* Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)\n\nExclusion Criteria:\n\n* Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)\n* Non-ambulatory patients\n* \\>50% loss of vertebral body height or spinal instability to due pathologic compression fracture\n* Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord\n* Rapid neurologic decline\n* Patients for whom an MRI of the spine is medically contraindicated\n* Pregnant women","ALL","18 Years",{"count":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.\n\nIn standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.",[72,73],"Spine Metastases","Metastasis Spine",[75,76],"Localized Metastasis","Spinal Column","2025-11-13",{"date":79,"type":80},"2025-11-14","ACTUAL",{"date":82,"type":80},"2021-03-14",{"date":84,"type":66},"2029-12-31",{"name":5,"class":6},1]